AstraZeneca Canada Inc. et al. v. Teva Canada Ltd. et al., (2013) 428 F.T.R. 269 (FC)

• Judge: Near, J.
• Court: Federal Court (Canada)
• Case Date: March 07, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2013), 428 F.T.R. 269 (FC);2013 FC 245

AstraZeneca Can. Inc. v. Teva Can. Ltd. (2013), 428 F.T.R. 269 (FC)

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Temp. Cite: [2013] F.T.R. TBEd. MR.038

AstraZeneca Canada Inc. and AstraZeneca UK Limited (applicants) v. Teva Canada Limited and The Minister of Health (respondents)

(T-1259-11; 2013 FC 245; 2013 CF 245)

Indexed As: AstraZeneca Canada Inc. et al. v. Teva Canada Ltd. et al.

Federal Court

Near, J.

March 7, 2013.

Summary:

The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent Teva Canada Limited respecting quietiapine fumarate extended release tablets until the expiry of patent number 2,251,944. The applicants brought two parallel applications: one addressing Teva's notice of allegation concerning 50 mg strength tablets and the other addressing Teva's notice of allegation concerning 150, 200, 300 and 400 mg strength tablets. Teva asserted that the patent was invalid on the grounds of obviousness and ambiguity.

The Federal Court dismissed the application where Teva's allegations of obviousness had an air of reality and the applicants had failed to establish that Teva's allegations of invalidity were unjustified.

Evidence - Topic 2403

Special modes of proof - Presumptions - Specific presumptions - Inference from failure to lead evidence - AstraZeneca applied for an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent Teva Canada respecting quietiapine fumarate extended release tablets until the expiry of patent number 2,251,944 - Teva asserted that the patent was invalid on the ground of obviousness - The Federal Court noted that in certain cases the court could look at the actual course of conduct followed by the inventors in determining obviousness - It was telling that AstraZeneca did not lead any evidence respecting the length or difficulty of the trial conducted or respecting whether their inventors possessed a knowledge base that was above that which should be attributed to the skilled person - Satisfied that Teva had given its allegations of invalidity an air of reality, the court drew an adverse inference from AstraZeneca's failure to provide evidence on these points - See paragraphs 63 and 64.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Notice of allegation (NOA) - AstraZeneca applied for an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent Teva Canada respecting quietiapine fumarate extended release tablets until the expiry of patent number 2,251,944 - Teva asserted that the patent was invalid on the grounds of obviousness and ambiguity - AstraZeneca challenged Teva's reliance on an article by Gefvert to point to a specific motivation to dose quietiapine less frequently on the basis that (1) the article was not relied on in Teva's notice of allegations (NOAs) and (2) the argument was not raised in its memorandum - The Federal Court concluded that the issue of a specific motive to create a sustained release version of quietiapine was squarely raised in the NOAs - Further, it was settled law that a second person (i.e., Teva) could respond to matters raised by an applicant in notice of compliance proceedings - Such a response did not constitute an expansion of the legal and factual basis of the notice of the NOAs - The court noted that one of AstraZeneca's witnesses had referred to the Gefvert article in his affidavit - Teva was thus well within its right to respond to the article in its submissions - Further, the issue of less frequent dosing as a motive was canvassed in Teva's written submission - While Teva did not appear to have relied on Gefvert for that specific proposition, the rules about raising new arguments pertained to shifting or raising new grounds for relief and not to relying on evidence which was already in the record to support a ground that was already in issue - See paragraphs 52 to 55.

Food and Drug Control - Topic 1108.2

Drugs - New Drugs - Notice of compliance - Prohibition order - AstraZeneca applied for an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent Teva Canada respecting quietiapine fumarate extended release tablets until the expiry of patent number 2,251,944 - Teva asserted that the patent was invalid on the ground of obviousness - The Federal Court dismissed AstraZeneca's application - Obviousness connoted "... something which would at once occur to a person skilled in the art who was desirous of accomplishing the end" (MedImmune Ltd. v. Novartis Pharmaceuticals UK Ltd. (2012, E.W.C.A.)) - The end, or the inventive concept, here was a sustained release formulation of quietiapine with a view to minimizing dose dumping and decreasing dosing frequency - The skilled person would have been led to combine the elements of the prior art to accomplish that end in the following manner - First, the prior art motivated the skilled person to find the solution that the patent addressed - Second, the prior art clearly taught that sustained release formulations were commonly used to achieve that purpose, the gelling agent used here (HPMC) being the one most commonly used in such formulations, in part because of the relatively straightforward manner in which it could be manufactured - It was more or less self-evident to try to obtain a sustained release formulation of quietiapine using HPMC and a person skilled in the art would have had a fair expectation of success - See paragraphs 65 and 66.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof - [See Evidence - Topic 2403 and Food and Drug Control - Topic 1105 ].

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof - AstraZeneca applied for an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent Teva Canada respecting quietiapine fumarate extended release tablets until the expiry of patent number 2,251,944 - Teva asserted that the patent was invalid on the grounds of obviousness and ambiguity - The Federal Court stated that "Teva bears the burden of giving its allegations of invalidity an air of reality. If it succeeds, the presumption of the patent's validity is rebutted, and AstraZeneca must establish, on a balance of probabilities, that Teva's allegations of invalidity are unjustified. ... If the evidence is 'evenly balanced (a rare event), the applicant (first person) will have failed to prove that the allegation of invalidity is not justified and will not be entitled to the order of prohibition' ..." - See paragraphs 9 and 10.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court stated that patents were to be construed purposively, having regard to the whole of the patent (i.e., the description and the claims) in order to ascertain the nature of the invention - Where the inventive concept of the claims was not discernible from the claims themselves because they presented a bare chemical formula, the court was to read the specification in the patent to determine the inventive concept of the claims - However, that did not give the court free rein to construe the claims as broadly or as narrowly as it wished - The patentee was "entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description" - See paragraphs 11 to 13.

Patents of Invention - Topic 1030

The specification and claim - Construction of patent - "Person skilled in the art" - What constitutes - AstraZeneca applied for an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent Teva Canada respecting quietiapine fumarate extended release tablets until the expiry of patent number 2,251,944 - Teva asserted that the patent was invalid on the ground of obviousness - It was agreed that the notional person skilled in the art would include both (i) a person with education and experience relevant to formulation (the formulator); and (ii) either a clinician with relevant experience respecting antipsychotic drugs or a researcher familiar with antipsychotic drugs and how they were used and worked to treat psychotic disorders (the clinician) - However, the parties disagreed on the skilled person's identity for the purpose of motivation - AstraZeneca asserted that the court should focus on the clinician as the skilled person for the purposes of motivation, whereas the formulator should be the focus of the self-evidence of the invention criterion - The Federal Court rejected AstraZeneca position, stating that "While it is true that the clinician and the formulator are both part of the 'team' that comprises the notional person skilled in the art in this case, it is a notional skilled person upon whom the characteristics of the real-life team are layered, and not a notional skilled team. As such, both clinician and formulator are equal participants in each step of the 'obvious to try' test." - See paragraph 50.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - [See Food and Drug Control - Topic 1108.2 ].

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court reviewed the test for obviousness under s. 28.3 of the Patent Act - See paragraphs 16 to 21.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - AstraZeneca applied for an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent Teva Canada respecting quietiapine fumarate extended release tablets until the expiry of patent number 2,251,944 - Teva asserted that the patent was invalid on the grounds of obviousness - The parties agreed that the "obvious to try" test was appropriate but disagreed on the parameters of the test - AstraZeneca focussed on the results of experimentation, maintaining that it had to be obvious that successful results would be achieved before any experimentation was carried out - Teva offered a less stringent proposition, asserting that a patent would be obvious if it was more or less self-evident to "try to obtain the invention" or, to conduct routine experimentation with a fair expectation of success - The Federal Court held that Teva's interpretation was more apt on the facts of the case - It was the idea of trying that constituted the inventive step - AstraZeneca's point might have been better received were the invention the idea of trying to obtain a sustained release formulation of quietiapine - However, the inventive concept here was the end product: a physical sustained release formulation of quietiapine - Motivation was the key factor - See paragraphs 35 to 37.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - [See Food and Drug Control - Topic 1108.2 ].

Cases Noticed:

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, refd to. [para. 9].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 394 F.T.R. 1; 2011 FC 547, refd to. [para. 9].

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2011), 385 F.T.R. 157; 2011 FC 239, refd to. [para. 9].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 414 F.T.R. 56; 2012 FC 767, affd. (2012), 440 N.R. 269; 2012 FCA 308, refd to. [para. 9].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 346 F.T.R. 78; 2009 FC 320, refd to. [para. 10].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 11].

Laboratoires Servier et al. v. Apotex Inc. et al.(2009), 392 N.R. 96; 2009 FCA 222, leave to appeal denied (2010), 405 N.R. 400 (S.C.C.), refd to. [para. 11].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2008), 381 N.R. 125; 2008 SCC 61, refd to. [para. 13].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2012), 436 N.R. 299; 2012 SCC 60, refd to. [para. 13].

Conor Medsystems Inc. v. Angiotech Pharmaceuticals Inc. et al., [2008] N.R. Uned. 259; [2008] UKHL 49, refd to. [para. 13].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 17].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (1999), 166 F.T.R. 161 (T.D.), refd to. [para. 31].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 2008 FC 825, affd. (2009), 392 N.R. 96; 2009 FCA 222, refd to. [para. 34].

Biovail Corp. et al. v. Canada (Minister of Health) et al. (2010), 361 F.T.R. 158; 2010 FC 46, refd to. [para. 34].

Medimmune Ltd. v. Novartis Pharmaceuticals UK Ltd. & Ors, [2012] EWCA Civ 1234, refd to. [para. 37].

Pfizer Canada Inc. et al. v. Pharmascience Inc. et al. (2013), 427 F.T.R. 6; 2013 FC 120, refd to. [para. 37].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 41].

Pfizer Canada Inc. et al. v. Ratiopharm Inc. et al. (2010), 371 F.T.R. 87; 2010 FC 612, refd to. [para. 41].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., [2007] F.C.R. 137; 351 N.R. 189; 2006 FCA 214, leave to appeal denied (2007), 364 N.R. 396 (S.C.C.), refd to. [para. 45].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 360 N.R. 174; 58 C.P.R. (4th) 97; 2007 FCA 83, refd to. [para. 53].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 303 F.T.R. 284; 2006 FC 1471, refd to. [para. 53].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2009), 352 F.T.R. 35; 2009 FC 638, affd. (2010), 408 N.R. 166; 2010 FCA 242, revd. (2012), 436 N.R. 299; 2012 SCC 60, refd to. [para. 54].

AstraZeneca AB et al. v. Apotex Inc. et al. (2004), 248 F.T.R. 1; 2004 FC 313, refd to. [para. 54].

Pozzoli SPA v. BDMO SA, [2007] EWCA Civ 588, refd to. [para. 56].

Teva UK Ltd. & Ors v. AstraZeneca AB, [2012] EWHC 655, refd to. [para. 56].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 2008 FC 538, refd to. [para. 62]

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 2005 FC 1725, refd to. [para. 67].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 28.3 [para. 16].

Counsel:

Yoon Kang, Colin B. Ingram and Andrew Mandlsohn, for the applicants;

David W. Aitken and Marcus Klee, for the respondent, Teva Canada Limited;

No appearance, for the respondent, The Minister of Health.

Solicitors of Record:

Smart & Biggar, Toronto, Ontario, for the applicants;

Osler, Hoskin & Harcourt LLP, Ottawa, Ontario, for the respondent, Teva Canada Limited;

William F. Pentney, Deputy Attorney General of Canada, Toronto, Ontario, for the respondent, The Minister of Health.

This application was heard at Toronto, Ontario, on January 21-23, 2013, by Near, J., of the Federal Court, who delivered the following reasons for judgment on March 7, 2013.